A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance
Information source: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Enteral Feeding Intolerance
Intervention: TD-8954 (Drug); Metoclopramide (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Theravance Biopharma R & D, Inc.
Summary
This study is being conducted to evaluate the safety, tolerability and early efficacy of IV
TD 8954 compared to metoclopramide in critically ill subjects, aged 18 to 85 years, who are
admitted to the intensive care require mechanical ventilation, and are intolerant to
enteral feeding.
Clinical Details
Official title: A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To evaluate the safety and tolerability of a single IV dose of TD-8954 in subjects with enteral feeding intolerance (EFI)by measuring AEs and ability to tolerate feeding.
Secondary outcome: To evaluate the pharmacokinetics (PK) of IV TD-8954 with lab values of Tmax.To evaluate the pharmacodynamics (PD) of IV TD-8954 in subjects with EFI based on gastric emptying as measured by scintigraphy. To evaluate the pharmacokinetics (PK) of IV TD-8954 with lab values of AUC. To evaluate the pharmacokinetics (PK) of IV TD-8954 with lab values of Cmax. To evaluate the pharmacokinetics (PK) of IV TD-8954 with breath tests
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Intubated, on mechanical ventilation, and anticipated to remain on mechanical
ventilation for 2 days after enrollment into the study
- Receiving enteral feeding and assessed to have developed EFI, as defined by a GRV
measurement ≥250 mL within the 24 hours before randomization
Exclusion Criteria:
- History of diabetic or idiopathic gastroparesis
- Screening blood glucose >15 mmol/L (270 mg/dL) while receiving insulin
- Impaired renal function, as defined by estimated glomerular filtration rate (eGFR)
<30 mL/min, as determined by the Cockcraft-Gault formula - Bilirubin concentration in
blood >2 times the upper limit of normal
- ALT or AST >3 times upper limit of normal
- Alkaline phosphatase >2 times upper limit of normal
- Contraindication to enteral feeding
- Opioid or other drug overdose as the primary reason for admission to Intensive Care
Unit (ICU)
- Receipt of a drug that can be used as a gastric prokinetic agent
- Receipt of agents known to directly influence the 5 HT4/acetylcholine prokinetic
mechanism
Locations and Contacts
Royal Adelaide Hospital, Adelaide, South Australia TBD, Australia
Additional Information
Starting date: January 2014
Last updated: December 15, 2014
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